Last Updated: November 8, 2026

Details for New Drug Application (NDA): 075405

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NDA 075405 describes CLADRIBINE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Pharmobedient, Apotex, and Hopewell Pharma, and is included in six NDAs. It is available from six suppliers. Additional details are available on the CLADRIBINE profile page.

The generic ingredient in CLADRIBINE is cladribine. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the cladribine profile page.

Summary for 075405

Tradename:	CLADRIBINE
Applicant:	Hikma
Ingredient:	cladribine
Patents:	0

Pharmacology for NDA: 075405

Medical Subject Heading (MeSH) Categories for 075405

Antineoplastic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 075405

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLADRIBINE	cladribine	INJECTABLE;INJECTION	075405	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9871	0143-9871-01	1 VIAL in 1 BOX, UNIT-DOSE (0143-9871-01) / 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Feb 28, 2000	TE:	AP	RLD:	No

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